Fecal Transplants: The FDA Steps In

Hi constant readers: I am traveling again, and while I’m in a far time zone, news has broken that you might be interested in. So while I don’t have a full understanding myself yet of what’s going on, I’m going to throw up what I’ve got, because I know how many people are interested in this.

Briefly: The US Food and Drug Administration has decided to bring the semi-outlawed — but very safe and very effective — procedure called “fecal transplant” under its auspices, ruling that to perform it, physicians must have applied for an “investigational new drug application,” or IND. This requires a lot of advance paperwork, 30 days of consideration, and does not return not a guaranteed yes. For the transplants, which have been performed informally but carefully by a growing number of physicians as a treatment (and often cure) for devastating C. difficile infection, it may improve safety, but it can’t help but impose obstacles and delay. (My past posts on fecal transplants here and here.)

The decision is confirmed in this letter from the FDA to the American Gastroenterological Association, which also explains the background in this post.

Even before the FDA did this, there were already hurdles for patients who are really suffering a great deal. First, there are few physicians who are providing this therapy. I have had patients drive over 8 hours to come for a treatment that is quite primitive but amazingly effective. For the doctor it’s time consuming and the reimbursement is very poor. Nonetheless, I have felt morally compelled to provide this therapy and as a result I have many thankful patients. Then there is the issue of insurance companies not covering the cost of donor testing, which costs $1500-2000. Now there’s the additional burden of the FDA red tape and the numerous documents required by institutional review boards.

So now I must apply for an IND number, which requires that I send the FDA my protocol. On the 30th day after receipt of my documents the FDA will let me know whether I can proceed. When I talked to the FDA officer yesterday she informed me that the FDA is only interested in fecal transplants with regards to safety. They want to ensure that donors are appropriately screened. Thus, I need to send them my protocol for donor testing and then I will get a ruling. I asked the officer what the FDA was looking for and was told that they can’t say but will either approve or not approve my protocol. Now wouldn’t it have made more sense for the FDA to review the literature and consult experts about what optimal testing of donors and safeguards should be for the procedure and simply require practitioners to follow their guideline instead of the guess-what-I’m-thinking-and-wait-30-days game?

Given how many scam artists and oversellers of the microbiome are out there I think some sort of increased protection or regulation is probably a good thing. But I am not sure what the best way to do this is. … given how little we know about FTs other than as treatment for Clostridium dificile infections it seems like one could make a reasonable argument for more regulation or caution. It seems strange though that we can do just about anything and everything we want to kill all the microbes around us with very little regulation and yet attempting to manipulate the microbes in and on us or add a few here and there is being regulated more.

And just in my tweetstream overnight, there was this discussion:

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The major digestive-disease societies and the American Society for Microbiology both began their annual meetings yesterday. Can’t imagine this won’t be a hot topic of conversation at both.

Update: From Dr. Judy Stone (who appears in the Storify above) an impassioned explanation of why this FDA decision will be bad for patients.